Quality Management System Strategy & Roadmap

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A biopharmaceutical company accustomed to collaborating with other corporations on product launches was preparing to introduce its own commercial product. In preparation for product approval, the company needed a harmonized QMS to support commercial-scale quality processes and workflows and provide internal capabilities to manage and monitor product quality with the contract manufacturing organizations (CMOs) with which they collaborate.

The client desired a prioritized roadmap defining actionable steps that could be taken to implement an efficient and scalable QMS, capable of maintaining compliance against commercial GMP standards.

CGI delivered a tactical, implementation-ready roadmap for the deployment of a new QMS to achieve the client’s goal of establishing the best path to a more efficient, scalable and manageable future state, capable of maintaining compliance against commercial GMP standards.
The roadmap depicted the key initiatives laid out across a high-level project plan.